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Details for New Drug Application (NDA): 201187

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NDA 201187 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Avanthi Inc, Sun Pharm Inds Ltd, Mallinckrodt Inc, West-ward Pharms Int, Teva, Actavis Elizabeth, Aurolife Pharma Llc, Impax Labs, Corepharma, and Par Pharm, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for NDA: 201187

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 201187

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 201187

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
oxymorphone hydrochloride
TABLET;ORAL 201187 ANDA CorePharma, LLC 64720-258 64720-258-10 100 TABLET in 1 BOTTLE (64720-258-10)
oxymorphone hydrochloride
TABLET;ORAL 201187 ANDA CorePharma, LLC 64720-259 64720-259-10 100 TABLET in 1 BOTTLE (64720-259-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 15, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 15, 2014TE:ABRLD:No

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